Kornimate/medical-research-clean huggingface dataset:
in-person vs. virtual delivery of a group-based prevention of postpartum depression

Conditions: Postpartum Depression

Summary: the goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.

depression is one of the most common perinatal complications, with 1 in 7 mothers qualifying for a diagnosis of postpartum depression (ppd) and even higher rates for those who identify as hispanic/latine, black or african american, american indian, or alaska native, or by multiple races or ethnicities. this project addresses this major gap in services to prevent ppd, particularly among socioeconomically disadvantaged and minoritized groups. it tests the benefit of a virtual perinatal preventive intervention in english and spanish to increase access, scalability and address the mental health needs of underserved populations. this project will test the virtual version against the in-person version of a service-ready efficacious preventive intervention in a randomized controlled trial (rct). this trial will provide a test of a preventive intervention with a strong evidence base that is scalable and can be delivered with fidelity by service providers in settings where obstetric care is received. in this project, pregnant women will be randomized to receive an evidence-based group prevention program (reach out, stay strong, essentials for new moms; rose) designed for perinatal populations either a) in person, delivered at the hospital where they are receiving prenatal care or b) virtually, delivered by the same staff via video conferencing, both offered in english and spanish. diverse pregnant individuals (n = 900) will be randomized to receive virtual or in-person rose. the central outcome, depression, will be assessed via redcap surveys, prenatally (before the program begins and at the end of gestation) and postpartum (approximately six-weeks, 3, 6, and 12-months after birth). electronic health records (ehrs) and surveys will be used to examine obstetric, mental health (e.g., standard of care depression screening), and sociodemographic factors linked to health disparities that may impact who benefits most.

Eligibility criteria:
inclusion criteria: * english or spanish speaking * less than 30 gestational weeks exclusion criteria: * none

Keywords: prenatal depression health disparities preventative intervention virtual therapy interpersonal therapy
early versus delayed operation for perforated appendicitis

Conditions: Appendiceal Abscess

Summary: the objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess. the hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.

this will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. this will be a pilot study. power calculations are not used for a pilot study. one group will undergo a primary laparoscopic appendectomy. the other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. all 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. the surgeon will not induce a significant confounding variable into this study. the laparoscopic appendectomy is approached in the same manner by all members of our group. those named on the form are qualified by the irb to obtain consent and/or will be accountable for overseeing the study. both groups will have the same antibiotic regiment. all data will be analyzed on intention-to-treat basis.

Eligibility criteria:
inclusion criteria: * patients with perforated appendicitis and an abdominal abscess diagnosed on ct scan. * children of any age will be included. exclusion criteria: * patients with immune deficiency * another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities). * acute sepsis or severe pain from perforation not allowing for delayed management.

Keywords: perforated appendicitis abscess appendectomy
utilization of nbi in assessing luminal inflammaion in ibd (unblind)

Conditions: Ulcerative Colitis (UC)

Summary: ulcerative colitis (uc) is a chronic inflammatory condition of unknown aetiology, characterized by a diffuse confluent mucosal inflammation of the colon starting from the rectum with a relapsing and remitting course. conventional endoscopy was thought to be a reliable parameter of disease activity, but microscopic inflammation can persist despite normal mucosal findings. histologically detectable inflammation is associated with a greater risk of subsequent relapse. a flare in uc activity is difficult to predict, but a simple, easily measured biological marker of relapse would be important in guiding the most appropriate therapy. recent technological advances in fiber optics, light sources, detectors, and molecular biology have stimulated development of numerous optical methods that promise to significantly improve our ability to evaluate human epithelium in vivo. these methods, collectively termed "optical biopsy," are nondestructive in situ assays of mucosal histopathology using light that can provide instantaneous tissue assessment. narrow band imaging (nbi) is a novel technique that enhances the diagnostic capability of endoscopes in characterising tissues by using filters in a redgreenblue (rgb) sequential illumination system. this results in improved mucosal contrast and detail. uc always involves the distal colon and activity is usually greatest in rectosigmoid area. this makes evaluation of the rectum and sigmoid an attractive marker in patients with uc. unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be affected by systemic disease and would be acceptable test for patients and physicians. we plan to evaluate the rectosigmoid mucosa in patients with uc by flexible endoscope using both white light and nbi endoscopy. these patients will be followed by for one year or until they relapse, whichever comes first. the aim of our study is to develop endoscopic biomarkers to predict relapse in acute and quiescent uc.


Eligibility criteria:
inclusion criteria: * adult patients referred for lower gastrointestinal endoscopy procedure will be recruited. * any age (1885 years), gender or ethnic background * able and willing to give an informed consent exclusion criteria: * patients known to be intolerant to endoscopy. * patients with severe lifethreatening comorbidity as judged by the investigator. * patients on therapy with anticoagulation that may preclude taking any biopsies * pregnant women or breast feeding mothers * patient with toxic megacolon * patients on medications known to cause bowel inflammation.
oral type i collagen for relieving scleroderma

Conditions: Scleroderma; Connective Tissue Diseases

Summary: diffuse systemic sclerosis (ssc), or scleroderma, is a connective tissue disease causing damage to skin and other organs. the purpose of this study is to determine if taking oral bovine type i collagen (ci) will improve the condition of ssc patients.

ssc is a chronic connective tissue disease that is caused by excess collagen deposits that damage the skin and other organs. this study will determine if a daily oral dose of bovine ci will improve the condition of patients with ssc. patients will be randomly assigned to one of two groups. the first group will receive 500 mcg bovine ci daily for 15 months; the second group will receive placebo. study visits will be conducted at months 4, 8, 12, and 15. patients will undergo physical examination and blood tests at each visit. patients will also be evaluated for modified rodnan skin score (mrss) and will be given health assessment questionnaires. a chest x-ray will be conducted at study entry and pulmonary function tests will be conducted at study entry and month 12.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diffuse systemic scleroderma (by american college of rheumatology criteria 1980) of 10 years or less * stable skin involvement by history or physical examination 6 months prior to study entry * stable modified rodnan skin score (mrss) for 1 month prior to study entry * stable mrss of 16 or more at screening and stable mrss between screening and baseline visit * agree to use acceptable forms of contraception exclusion criteria: * participation in another clinical research study involving evaluation of another investigational drug within 90 days prior to study entry * concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study * systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents, such as l-tryptophan, tainted rapeseed oil, vinyl chloride, or bleomycin * limited and localized (morphea) or linear ssc * tenderness or swelling of the extremities (eosinophilic fasciitis) * pregnancy * use of certain medications * allergy to beef or dairy products * nonsteroidal anti-inflammatory drugs (nsaids) within 1 week before baseline visit. aspirin at 325 mg or less daily for stroke or heart attack prevention is allowed. * use of herbal and some alternative therapies * any organ transplant or stem cell transplant

Keywords: systemic scleroderma (ssc) bovine type i collagen (ci) multicenter
outpatient follow-up on demand in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a two-year randomized controlled trial with rheumatoid arthritis (ra) patients. patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. patients were evaluated at baseline, year 1 and 2, including assessment of disease activity and reporting of outcomes measures on a touch screen at the clinic.

a two-year randomized controlled trial with rheumatoid arthritis (ra) patients. at baseline, patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. patients were evaluated at baseline, year 1 and 2, including assessment of disease activity (das-28), blood tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome measures. the objective of the study was to compare an outpatient system for danish ra patients based on patient self-controlled outpatient follow up on demand, open outpatient clinic programme with traditional scheduled routine follow-up regarding patient satisfaction and effect on traditional disease markers. the danish national patient registry (danbio) was used to identify eligible patients with ra. at pre-planned routine visits with the rheumatologist, identified patients were screened according to inclusion and exclusion criteria. the intervention group had no scheduled appointments at the outpatient clinic, but they could book acute appointments with their contact rheumatologist within 5 days or less whenever they deemed it necessary. they also had access to nurse-led consultations without pre-booked appointments and to a nurse-led telephone helpline

Eligibility criteria:
inclusion criteria: ra. disease duration of at least 1 year. exclusion criteria: patients treated with monthly intravenous biological medicine

Keywords: follow-up on demand
function of high density lipoproteins in acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: high density lipoproteins (hdl) have many effects that protect against cardiovascular diseases. in an acute heart attack (acute coronary syndrome -acs), hdl change in composition and structure, reflecting the inflammatory environment that accompanies an acs. the investigators will examine the function of hdl during an acs and again when the patient has recovered.

high density lipoproteins (hdl) have pleiotropic effects associated with protection against atherosclerosis. these effects include cellular cholesterol efflux, anti-inflammatory and anti-oxidant effects, increase in nitric acid (no) production from vascular endothelial cells and differentiation of endothelial progenitor cells for repair at sites of vascular injury. the measurement of the cholesterol mass within hdl (hdl-c) does not provide an adequate measure of hdl function. the investigators therefore propose to test and validate biomarkers of hdl function in patients with acute coronary syndromes (acs). hypothesis: hdl lose their cardiovascular protective functions in acs. the investigators hypothesize that these changes are transient and partly normalize within 12 weeks. in this proposal, the investigators will examine the function of hdl in acute coronary syndromes (acs) and 12 weeks later, in the recovery phase. acute coronary syndromes are characterized by an acute inflammatory reaction, a marked decrease in hdl in plasma and a shift of the hdl proteome to an inflammatory phenotype.

Eligibility criteria:
inclusion criteria: * men and women 18-80 years of age * acute coronary syndrome within 72 hours of presentation * elevated tropinins (t or i) exclusion criteria: * refusal to participate * inability to return for a 12 week follow-up visit * hemodynamic instability requiring vasopressor support, mechanical ventricular assist devices, the need for coronary artery bypass surgery * lack of documented atherosclerotic cad * uncontrolled hypertension * triglycerides≥5mmol/l * severe obesity (bmi≥35) * alcohol intake\>21 drinks/week * presence of thyroid, hepatic, or renal disease * autoimmune disease or any chronic or acute infectious or inflammatory illness

Keywords: high density lipoproteins acute coronary syndromes cellular cholesterol efflux hdl: proteomics nitric acid production
effects of finasteride on serum prostate-specific antigen (0906-111)

Conditions: Androgenetic Alopecia

Summary: a clinical study to collect additional data in order to characterize the reduction in psa with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the ages of 40 to 60 years.


Eligibility criteria:
inclusion criteria : * men 40 to 60 years of age, and in good general physical and mental health, with androgenetic alopecia exclusion criteria : * history of previous bladder surgery, acute urinary retention, urethral strictures, repeated urethral catheterizations, repeated urinary tract infections, or active urinary tract infections * history of treatment with finasteride (proscar or propecia) or hypersensitivity to any component of finasteride.
coordinated reset deep brain stimulation for essential tremor

Conditions: Essential Tremor; Upper Extremity Essential Tremor

Summary: deep brain stimulation (dbs) is a surgical procedure for the treatment of essential tremor (et). a novel approach to current dbs approaches is called coordinated reset dbs (cr-dbs) which uses different patterns of stimulation at lower currents and can address the limitations of traditional dbs that uses continuous high amplitude, high frequency stimulation. this study will evaluate the feasibility, safety and short-term efficacy of thalamic cr-dbs in upper extremity et. the goal of this study is to evaluate the safety and short-term efficacy of thalamic cr- dbs in et, including the acute (during cr-dbs) and carryover (following dbs cessation) effects, and compare these to those induced by clinically optimized t-dbs. to achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (ue) et. the first aim is to identify the spatial location and peak frequency of tremor related oscillatory activities in vim (phase i). the second aim is to compare the acute effects of thalamic cr-dbs to clinically optimized t-dbs (phase ii).


Eligibility criteria:
inclusion criteria: * diagnosis of essential tremor (et) * age of 21 or over * will be implanted with boston scientific vercise rechargeable genus deep brain stimulation (dbs) system * 7 tesla (7t) mri pre-operative scan under noam harel phd's (center for magnetic research (university of minnesota irb #1210m22183) protocol "imaging of dbs targets at 7t mri" * planned post-operative ct scan exclusion criteria: * history of musculoskeletal disorders that affect movement of the limbs or gait * other significant neurological disorder * history of dementia or cognitive impairment (mini-mental score \&lt; 26) * significant psychiatric disease * on medication that could cause tremor * prior brain surgery * pregnant women * evidence of non-et central nervous system disease or injury for at least three (3) months prior to implantation * any suspicion of parkinsonian tremor, including presence of parkinsonian features such as bradykinesia, rigidity, or postural instability * other significant medical disorder that could impede study participation
post-marketing safety study following long-term prophylactic optivatetreatment in subjects with severe haemophilia a

Conditions: Haemophilia A

Summary: primary objective: to assess post-marketing immunogenicity of optivate® by monitoring plasma inhibitor levels for at least 100 exposure days (eds) for each subject. secondary objectives: to assess efficacy and tolerability by monitoring fviii recovery and adverse events

the primary efficacy endpoint is to assess immunogenicity of optivate® by monitoring plasma inhibitor level for at least 100 eds for each subject. fviii inhibitor evaluation fviii inhibitor screen data will be listed. fviii quantitative inhibitor results will be listed. shift tables will present the number of subjects with positive (≥ 0.6 bu) and negative (\< 0.6 bu) results and those for whom the results change during the study. the number of exposure days until development of inhibitors will be summarised. for the secondary endpoints: descriptive statistics will be presented on the number of recoveries at each timepoint and for each subject. these will be presented for each visit and for each subject and then for each batch of fviii/ optivate® used. all the ae data (from crf and study diary) will be pooled together and reported in terms of the type, duration, treatment and/or severity.

Eligibility criteria:
inclusion criteria: * written informed consent or, if less than 18 years of age written assent (where possible) and their parent/guardian's written informed consent. * severe haemophilia a (\< 1%# fviii:c). * previously treated patients (ptps) with \> 150 exposure days on prior factor viii therapy (of which at least the last 50 eds or 2 years treatment can be confirmed by way of subject records). * immunocompetent with cd4 count \> 200 / µl. * hiv negative or a viral load \< 200 particles / µl. * subjects suffering from severe haemophilia a (\<2%) may be enrolled, but only after approval by bpl. subjects with a factor viii of \<2% may not constitute more than 50% of the total patient population. a separate statistical evaluation will be conducted for the \<1% and \<2% populations. exclusion criteria: * • history of inhibitor development to fviii or a positive result on the nijmegen bethesda at screening (quantitative result of \> 0.6 bu) prior to the administration of optivate®. * known or suspected hypersensitivity to the investigational medicinal product or its excipients. * clinically significant liver disease, renal disease, or coagulopathy other than haemophilia a. * history of unreliability or non cooperation (including not being able to complete the study diary). * participating in, or have taken part in another trial within the last 30 days.

Keywords: haemophilia a
detection of ischemia in asymptomatic diabetics

Conditions: Type 2 Diabetes Mellitus

Summary: asymptomatic subjects with type 2 diabetes mellitus were randomized to either screening with tc-99m sestamibi adenosine spect imaging or no screening. all patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction. the aims are: 1. to prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with type 2 diabetes mellitus. 2. to identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate. 3. to assess progression of (silent) myocardial ischemia after 3 years. 4. to assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.


Eligibility criteria:
inclusion criteria: * age 50-75 years * type 2 diabetes mellitus exclusion criteria: * angina or anginal equivalent * abnormal rest ecg (q or st depression) * known cad * stress testing within the last 3 years

Keywords: silent ischemia type 2 diabetes mellitus screening cardiac outcome prevalence silent myocardial ischemia cardiac outcome in screened and not-screened subjects
intra-surgery high-resolution specimen pet/ct imager for margin assessment in early-stage breast cancer

Conditions: Breast Cancer; Breast-conserving Surgery

Summary: this study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial. the primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (idc) patients by high-resolution specimen positron emission tomography/computed tomography (pet/ct) imaging.

the rationale of this study is to examine the non-inferiority of intraoperative high-resolution specimen pet/ct imaging in early-stage breast cancer for the identification of all positive margins of the invasive component during breast cancer surgery (bcs) as compared to standard-of-care gross pathology evaluation. the pet/ct specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard.

Eligibility criteria:
inclusion criteria: * females with an age over 18 years; * confirmed breast cancer with indication to undergo bcs (stage i-ii with tumor ≤2.5 in greatest dimension); * vacuum-assisted core breast biopsy is allowed for non-invasive tumors only; * able to understand treatment protocol and informed consent form; * estimated by the investigator to be compliant for study participation. exclusion criteria: * general or local contra-indication for bcs; * previous breast surgery; * inflammatory breast cancer; * radiotherapy of the ipsilateral breast; * vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm); * pregnancy or lactation; * participation in other clinical studies with a radiation exposure of more than 1 msv in the past year; * active bacterial, viral or fungal infection.